SAT0625 TREATMENT RESPONSE AND DRUG RETENTION RATES IN 23,956 BIOLOGIC-NAÏVE PATIENTS WITH AXIAL SPONDYLOARTHRITIS INITIATING TNFI TREATMENT – ROUTINE CARE DATA FROM 12 REGISTRIES IN THE EUROSPA COLLABORATION
Authors: Lykke Ørnbjerg, Cecilie Heegaard Brahe, Anne Gitte Loft, Johan Askling, Adrian Ciurea, Heřman Mann, Fatos Onen, Eirik Kristianslund, Dan Nordström, Maria Jose Santos, Catalin Codreanu, Manuel Pombo-Suarez, Ziga Rotar, Björn Gudbjornsson, Daniela DI Giuseppe, Michael Nissen, Karel Pavelka, Merih Birlik, Joe Sexton, Kari Eklund, Anabela Barcelos, Ruxandra Ionescu, Carlos Sánchez-Piedra, Matija Tomsic, Arni Jon Geirsson, Irene van der Horst-Bruinsma, Gareth T. Jones, Florenzo Iannone, Lise Hyldstrup, Niels Steen Krogh, Merete L. Hetland, Mikkel Östergaard
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The efficacy of Tumour Necrosis Factor Inhibitor (TNFi) in patients with axial spondyloarthritis (axSpA) has been investigated in randomized controlled trials (RCTs) with strict inclusion and exclusion criteria. Patients treated in routine care are more heterogeneous and only ≈20-30% of patients receiving TNFi in routine care would have been eligible to be enrolled in the RCTs<sup>1</sup>. This emphasizes the need for real-world observational data as a valuable supplement to RCTs. Studying large patient groups from several European countries would increase the external validity of the results. Particularly, large data sets from patients with non-radiographic axSpA (nr-axSpA) are lacking. <h3>Objectives</h3> To investigate TNFi retention rates at 12 months (primary objective), 6 and 24 months, and response rates at the same time-points in biologic-naïve patients with axSpA from the EuroSpA Research Collaboration. Furthermore, to investigate if findings vary between patients with nr-axSpA and ankylosing spondylitis (AS). <h3>Methods</h3> Data from 12 European quality registries in rheumatology, prospectively collected in routine care, were anonymized and uploaded through the secure Virtual Private Network pipelines to the EuroSpA server. Baseline characteristics were investigated with non-parametric descriptive statistics. TNFi retention rates (Kaplan-Meier statistics), and Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (&lt;1.3) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤4 were assessed, including LUNDEX adjustment<sup>1</sup>. For patients initiating 1<sup>st</sup> TNFi after January 1<sup>st</sup> 2009, the following sub-cohorts were also studied: patients fulfilling the ASAS criteria for axSpA, the modified New York criteria for AS and ASAS criteria for nr-axSpA. <h3>Results</h3> First TNFi treatment was initiated in 23,956 axSpA patients. Baseline characteristics of the pooled population are shown in the <b>Table</b>. The 12-month retention rate (95%CI) was 80% (79-80%); 71-94% across registries (<b>Figure</b>). At 6 months, overall ASDAS Inactive disease/BASDAI≤4 rates were: 33%/72% (LUNDEX adjusted: 27%/59%). Number of patients initiating 1<sup>st</sup>TNFi after 2009 and registered with fulfilment of axSpA (ASAS) was 6,097, Ankylosing Spondylitis (modified New York Criteria) was 2,935 and non-radiographic axSpA (nr-axSpA) was 1,178. We observed lower retention rate and marginally lower LUNDEX adjusted response rates in nr-axSpA patients (<b>Table</b>). <h3>Conclusion</h3> In routine care ≈1/3 of patients with axSpA initiating 1<sup>st</sup> TNFi treatment were in ASDAS inactive disease after 6 months, while ¾ achieved BASDAI ≤4. Four out of five patients continued treatment after 1 year. Results were slightly inferior in nr-axSpA as compared to AS. <h3>References</h3> [1] Clin Exp Rheumatol, 2018, 36(6):1068-1073 [2] Arthritis Rheum, 2006, 54(2): 600-6 <h3>Acknowledgement</h3> Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration. <h3>Disclosure of Interests</h3> Lykke Ørnbjerg Grant/research support from: Unrestricted grant: Novartis, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Anne Gitte Loft: None declared, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Fatos Onen: None declared, Eirik kristianslund: None declared, Dan Nordström Grant/research support from: MSD, Pfizer, Consultant for: AbbVie, BMS, MSD, Novartis, Roche, Pfizer, UCB, Speakers bureau: Novartis, UCB, Maria Jose Santos: None declared, Catalin Codreanu: None declared, Manuel Pombo-Suarez: None declared, Ziga Rotar: None declared, Björn Gudbjornsson: None declared, Daniela Di Giuseppe: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Merih Birlik: None declared, Joe Sexton: None declared, Kari Eklund: None declared, Anabela Barcelos: None declared, Ruxandra Ionescu: None declared, Carlos Sánchez-Piedra: None declared, Matija Tomsic: None declared, Arni Jon Geirsson: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gareth T. Jones Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis, Mikkel Östergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB